Oleeva Fabric
FDA 510(k) K023136 · Bio Med Sciences, Inc.
510(k) numberK023136
Submission
- Device name
- Oleeva Fabric
- Applicant
- Bio Med Sciences, Inc.
Allentown, PA, US - Received
- September 20, 2002
- Decision date
- October 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDA – Elastomer, Silicone, For Scar Management
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4025
- Specialty
- General, Plastic Surgery
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| K024057 | Curad Scar TherapyMDA · Traditional | Beiersdorf, Inc. | 06/18/2003SE |
| K024160 | Neosporin Scar SolutionMDA · Traditional | Warner-Lambert Co. | 03/17/2003SE |
| K023678 | Dimisil Scar GelMDA · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 01/23/2003SE |
| K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar…MDA · Traditional | Medtrade Products , Ltd. | 02/14/2002SE |
More from Medtrade Products , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K002109 | Oleeva FoamMDA · Traditional | 08/31/2000SE |
| K990042 | Silon Dual-DressFRO · Traditional | 03/19/1999SE |
| K982036 | Silon Scar StripsMDA · Traditional | 08/06/1998SE |
| K952546 | Silon Silicone Textile CompositeMDA · Traditional | 08/07/1995SE |
| K946362 | Silon Silicone Foam SheetingMDA · Traditional | 07/13/1995SE |
| K945892 | Silon(R) Silicone Thermoplastic SheetingMDA · Traditional | 03/03/1995SE |
| K932214 | Silon Silicone Gel SheetMDA · Traditional | 01/06/1994SE |
| K923150 | Silon Transparent Wound DressingsMGP · Traditional | 08/27/1992SE |
| K912032 | Silon(Tm) Transparent Wound DressingMGP · Traditional | 08/20/1991SE |
Questions and answers
When was Oleeva Fabric cleared by the FDA?
Oleeva Fabric (K023136) received a 510(k) decision of Substantially Equivalent on October 16, 2002, 26 days after the submission was received.
What is the product code of K023136?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.